Dassault Systèmes signs Research Agreement with the FDA

 

Dassault Systèmes and the U.S. Food and Drug Administration have concluded a five-year extension of their collaboration on the 3DEXPERIENCE platform in order to develop a new digital tool to enable more efficient regulatory review of cardiovascular and medical devices.

The project with the Living Heart simulated 3D heart model will examine the use of heart simulation as a source of digital evidence for new cardiovascular device approvals. This new digital process is intended to be more efficient and less expensive than current ones, whose delays and costs can impede patient access to novel treatments.

The second phase of the ongoing collaboration supports the 21st Century Cures Act, using virtual patients based on computational modeling and simulation to improve the efficiency of clinical trials for new device designs.


Analysis

Both Dassault Systèmes and the FDA are once again recognising the transformative impact of modeling and simulation on public health and patient safety. The Avicenna Secretariat will not omit to share this information with policymakers and regulators in future interactions. Globally, policymakers and regulators should note that the FDA encourages research to facilitate the introduction of safe and effective therapeutic solutions by supporting the development of CM&S.

Tina Morrison, Ph.D., Deputy Director in the Division of Applied Mechanics, FDA, has also positively commented this extension of cooperation:

“Modeling and simulation can help to inform clinical trial designs, support evidence of effectiveness, identify the most relevant patients to study, and assess product safety. In some cases, in silico clinical trials have already been shown to produce similar results as human clinical trials”.

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